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Study on the mechanism of Lingnan fire needling on brain gut axis in functional dyspepsia with liver depression and spleen deficiency syndrome

注册号：

Registration number：

ITMCTR2100005398

最近更新日期：

Date of Last Refreshed on：

2021-12-12

注册时间：

Date of Registration：

2021-12-12

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

岭南火针对FD肝郁脾虚证脑肠轴作用机制研究

Public title：

Study on the mechanism of Lingnan fire needling on brain gut axis in functional dyspepsia with liver depression and spleen deficiency syndrome

注册题目简写：

English Acronym：

研究课题的正式科学名称：

岭南火针对功能性消化不良肝郁脾虚证脑肠轴作用机制研究

Scientific title：

Study on the mechanism of Lingnan fire needling on brain gut axis in functional dyspepsia with liver depression and spleen deficiency syndrome

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

ChiCTR2100054269 ; ChiMCTR2100005398

申请注册联系人：

常少琼

研究负责人：

常少琼

Applicant：

ShaoqiongChang

Study leader：

ShaoqiongChang

申请注册联系人电话：

Applicant telephone：

13631396263

研究负责人电话：

Study leader's telephone：

13631396263

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

changshaoqiong90280@gzucm.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

changshaoqiong90280@gzucm.edu.cn

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

中国广东省广州市白云区机场路16号

研究负责人通讯地址：

中国广东省广州市白云区机场路16号

Applicant address：

16 Jichang Road, Baiyun District, Guangzhou, Guangdong, China

Study leader's address：

16 Jichang Road, Baiyun District, Guangzhou, Guangdong, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

广州中医药大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

NO.K【2021】085

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

广州中医药大学第一附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Guangzhou University of traditional Chinese M

伦理委员会批准日期：

Date of approved by ethic committee：

2021/11/24 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

广州中医药大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

中国广东省广州市白云区机场路16号

Primary sponsor's address：

16 Jichang Road, Baiyun District, Guangzhou, Guangdong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

广州市

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

广州中医药大学第一附属医院

具体地址：

中国广东省广州市白云区机场路16号

Institution
hospital：

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Address：

16 Jichang Road, Baiyun District, Guangzhou, Guangdong, China

经费或物资来源：

研究者自筹

Source(s) of funding：

The researchers collect their own funds.

研究疾病：

功能性消化不良

研究疾病代码：

Target disease：

Functional dyspepsia

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

非随机对照试验

Non randomized control

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

从自主神经系统平衡性、主要脑肠肽的前后变化，观察岭南火针对脑肠轴的作用，结合今后动物实验结果，探讨岭南火针对功能性消化不良肝郁脾虚证脑肠轴的作用机制。同时，观察岭南火针干预功能性消化不良（FD）肝郁脾虚证的临床效果和生存质量状态改善情况，证实岭南火针对FD肝郁脾虚证的疗效，从而指导岭南火针在功能性胃肠病的应用，为今后火针在胃癌防治中应用提供基础。

Objectives of Study：

From the changes of autonomic nervous system balance and the main brain gut peptides, the effect of Lingnan fire needling on brain gut axis was observed. Combined with the results of future animal experiments, we hope to study the mechanism of Lingnan fire needling on brain gut axis of liver depression and spleen deficiency syndrome of functional dyspepsia. At the same time, by observing the clinical effect of Lingnan fire needling on liver depression and spleen deficiency syndrome of functional dyspepsia (FD) and the improvement of quality of life, this study may confirm the curative effect of Lingnan fire needling on FD liver depression and spleen deficiency syndrome, so as to guide the application of Lingnan fire needling on functional gastrointestinal diseases and provide a basis for the application of fire needling on the prevention and treatment of gastric cancer in the future.

药物成份或治疗方案详述：

本项目采取非盲、非随机模式，根据患者各自意愿选择火针干预方案或者莫沙必利干预方案，分别纳入试验组和对照组，每组约65例。 1.试验组：采用火针干预方案。 选穴：中脘、足三里、内关、脾俞、胃俞、肝俞、太冲、阳陵泉 操作方法： 先针刺中脘、足三里、内关、脾俞、胃俞、阳陵泉和太冲。针刺完毕后，火针中脘、足三里、脾俞、肝俞、太冲。每4天治疗1次，连续治疗4周。 2.对照组：莫沙必利干预方案 口服莫沙必利片，每次5mg，一天三次，饭前服用，连续服用4周。 3.两组都辅助给予起居、生活、饮食健康指导。

Description for medicine or protocol of treatment in detail：

This project is a non blind and non randomized study. According to the wishes of the patients, fire acupuncture intervention or mosapride intervention were selected and entered into the experimental group or the control group, with about 65 cases in each group. 1. Experimental group: fire needle intervention scheme was adopted. Selected acupoints: Zhongwan, Zusanli, Neiguan, Pishu, Weishu, Ganshu, Taichong, Yanglingquan Operation: First acupuncture Zhongwan, Zusanli, Neiguan, Pishu, Weishu, Yanglingquan and Taichong. After acupuncture, fire needling was applied to Zhongwan, Zusanli, Pishu, Ganshu and Taichong. Once every 4 days for 4 weeks. 2. Control group: mosapride intervention scheme was adopted. Oral mosapride tablets, 5mg each time, three times a day, before meals for 4 weeks. 3. Both groups were assisted with daily life and diet health guidance.

纳入标准：

1）年龄介于18-65周岁； 2）符合功能性消化不良的诊断标准； 3）符合中医肝郁脾虚证； 4）患者功能性消化不良症状频率、症状严重程度II级以上； 5）患者自愿参与本研究，并签署书面知情同意书，愿意配合随访。

Inclusion criteria

1) Age between 18-65 years old; 2) Accord with the diagnostic criteria of functional dyspepsia; 3) Accord with the syndrome of liver depression and spleen deficiency in traditional Chinese medicine; 4) The frequency and severity of symptoms of functional dyspepsia were above grade II; 5) Patients volunteered to participate in the study, signed informed consent and were willing to cooperate with the study.

排除标准：

1）筛选前2周内接受过功能性消化不良药物或针灸治疗的患者； 2）筛选检查前2周内接受过任何手术的患者； 3）合并有糖尿病、凝血功能障碍或严重皮肤疾病的患者； 4）筛选检查时患者丙氨酸氨基转移酶(ALT)或天门冬氨酸氨基转移酶（AST）大于或等于本中心规定正常值上限的1.5倍，或内生肌酐清除率（CCr）大于本中心规定的正常值上限； 5）筛选检查时患者血常规白细胞总数（WBC）大于10.0X109/L或小于1.0X109/L； 6）患者有免疫缺陷疾病史（如HIV等），或癌症、恶性肿瘤病史，或自身免疫性疾病史，或心、脑血管严重疾病，或患有其他可能显著减少预期寿命疾病； 7）具有任何可能影响方案依从性的疾病史（如严重精神障碍、认知功能障碍、药物滥用或成瘾等）； 8）妊娠或哺乳期妇女，或有生育能力且不愿/无法采取有效避孕措施者； 9）已知对本研究用药所含成分过敏者； 10）筛选检查前6个月内曾参加过任何药物临床试验者； 11）研究者判断不宜参加本研究的患者。

Exclusion criteria：

1) Patients who had received functional dyspepsia drugs or acupuncture treatment within 2 weeks before screening; 2) Patients who underwent any surgery within 2 weeks before screening; 3) Patients with diabetes, coagulation disorders or severe skin diseases 4) During screening examination, the alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of the patient is greater than or equal to 1.5 times of the upper limit of normal value specified by the center, or the endogenous creatinine clearance (CCR) is greater than the upper limit of normal value specified by the center; 5) During screening examination, the total white blood cell count (WBC) of patients is greater than 10.0x109/l or less than 1.0x109/l; 6) The patient has a history of immune deficiency diseases (such as HIV), or a history of cancer, malignant tumor, or autoimmune diseases, or serious cardiovascular and cerebrovascular diseases, or other diseases that may significantly reduce life expectancy; 7) Have any history of diseases that may affect program compliance (such as severe mental disorders, cognitive impairment, drug abuse or addiction); 8) Pregnant or lactating women, or those who are unwilling / unable to take effective contraceptives; 9) Those who are known to be allergic to the ingredients contained in the drug used in this study; 10) Those who have participated in any drug clinical trial within 6 months before screening examination; 11) The investigator judged that patients should not participate in this study

研究实施时间：

Study execute time：

从From 2021-11-01

至To      2022-12-31

征募观察对象时间：

Recruiting time：

从From 2021-12-12

至To      2022-06-30

干预措施：

Interventions：

组别：

试验组

样本量：

65

Group：

Experimental group

Sample size：

干预措施：

岭南火针方案

干预措施代码：

Intervention：

Fire needle intervention scheme was adopted.

Intervention code：

组别：

对照组

样本量：

65

Group：

Control group

Sample size：

干预措施：

莫沙必利干预方案

干预措施代码：

Intervention：

Mosapride intervention scheme was adopted.

Intervention code：

样本总量 Total sample size ： 130

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

广东省

市(区县)：

广州市

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

广州中医药大学第一附属医院

单位级别：

三级甲等公里医院

Institution/hospital：

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Level of the institution：

Level Three-A public hospital

测量指标：

Outcomes：

指标中文名：

谷氨酸

指标类型：

附加指标

Outcome：

Glutamate

Type：

Additional indicator

测量时间点：

干预前1周和干预4周后

测量方法：

酶联免疫检测

Measure time point of outcome：

One week before intervention and four weeks after intervention

Measure method：

Elisa

指标中文名：

5-羟色胺

指标类型：

次要指标

Outcome：

5-hydroxytryptamine

Type：

Secondary indicator

测量时间点：

干预前1周、干预2周后和干预4周后

测量方法：

酶联免疫检测

Measure time point of outcome：

One week before intervention, two weeks after intervention and four weeks after intervention

Measure method：

Elisa

指标中文名：

临床有效率

指标类型：

主要指标

Outcome：

Clinical effective rate

Type：

Primary indicator

测量时间点：

干预4周后

测量方法：

调查评价

Measure time point of outcome：

After 4 weeks of intervention

Measure method：

Investigation and evaluation

指标中文名：

自主神经系统活性

指标类型：

附加指标

Outcome：

Autonomic nervous system activity

Type：

Additional indicator

测量时间点：

干预前1周和干预4周后

测量方法：

仪器检测

Measure time point of outcome：

1 week before intervention and 4 weeks after intervention

Measure method：

Instrument detection

指标中文名：

胃动素

指标类型：

次要指标

Outcome：

Motilin

Type：

Secondary indicator

测量时间点：

干预前1周、干预2周后和干预4周后

测量方法：

酶联免疫检测

Measure time point of outcome：

One week before intervention, two weeks after intervention and four weeks after intervention

Measure method：

Elisa

指标中文名：

促肾上腺皮质激素释放因子

指标类型：

附加指标

Outcome：

Corticotropin releasing factor

Type：

Additional indicator

测量时间点：

干预前1周和干预4周后

测量方法：

酶联免疫检测

Measure time point of outcome：

One week before intervention and four weeks after intervention

Measure method：

Elisa

指标中文名：

SF-36健康状况调查表积分

指标类型：

附加指标

Outcome：

SF-36 health status questionnaire score

Type：

Additional indicator

测量时间点：

干预前1周、干预4周后、干预后6个月

测量方法：

量表评价

Measure time point of outcome：

One week before intervention, four weeks after intervention and six months after intervention

Measure method：

Scale evaluation

指标中文名：

自主神经系统平衡性

指标类型：

附加指标

Outcome：

Autonomic nervous system balance

Type：

Additional indicator

测量时间点：

干预前1周和干预4周后

测量方法：

仪器检测

Measure time point of outcome：

1 week before intervention and 4 weeks after intervention

Measure method：

Instrument detection

指标中文名：

总体症状积分

指标类型：

主要指标

Outcome：

Overall symptom score

Type：

Primary indicator

测量时间点：

干预4周后

测量方法：

量表评价

Measure time point of outcome：

After 4 weeks of intervention

Measure method：

Scale evaluation

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 65 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

不随机，根据患者意愿选择干预方案从而进入相应研究组。

Randomization Procedure (please state who generates the random number sequence and by what method)：

Not random. The intervention was selected according to the patient's wishes and enter the corresponding study group.

盲法：

不设盲

Blinding：

No blindness.

是否共享原始数据：

IPD sharing：

是

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

不共享

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Not shared

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

用病例记录表采集数据，数据保存并管理于研究中心的健康管理数据库。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The data were collected with case record form, and the data were saved and managed in the health management database of the research center.

数据管理委员会：

Data Managemen Committee：

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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